2024-07-28 20:38:29
“Side effects such as cerebral edema are frequent compared to the effectiveness”
Domestic flights without ‘alternatives’ likely to be launched early next year
“Each country has a different judgment of ‘side effects-benefits’”
Alzheimer’s treatment drug ‘Rekemvi’, which was scheduled to be launched in Korea early next year, failed to gain approval in Europe due to concerns about side effects such as cerebral edema.
The European Medicines Agency (EMA) recommended on the 26th (local time) that it reject the approval of Rekemvi, an Alzheimer’s treatment jointly developed by Biogen and Eisai. This is because side effects occur frequently compared to its effect in delaying cognitive decline.
The EMA stated that “the observed effects of Rekemvi do not outweigh the risk of serious side effects associated with the drug.” The final approval of Rekemvi is decided by the European Commission, but most follow the EMA’s recommendations. The side effect of Rekemvi that the EMA pointed out is ‘amyloid-related imaging abnormalities (ARIA)’, which cause brain swelling and bleeding. Amyloid is currently the most likely cause of Alzheimer’s disease, and many pharmaceutical companies have been trying to develop antibody treatments to block amyloid accumulation in the brain. Rekemvi is one of them.
The problem is that these antibodies damage blood vessel walls while trying to block amyloid. Fluid leaks through the damaged blood vessel walls, causing brain swelling, or blood leaks, causing brain hemorrhage. The EMA noted that “some patients suffered serious side effects that required hospitalization.”
However, it seems that EMA’s decision this time will not have a big impact on the domestic launch schedule of Rekembi. This is because there is no treatment that can be an alternative to Rekembi right now. Rekembi received approval from the US Food and Drug Administration (FDA) in July of last year, and was approved by regulatory authorities in Japan, China, Korea, and Israel. It has completed its launch in the US, Japan, and China, and it is scheduled to be launched early next year in Korea, which approved Rekembi in May of this year.
Kim Young-soo, a professor at Yonsei University College of Pharmacy, said, “All treatments have side effects. The reason why approval varies from country to country is because there are different judgments about which side effects or benefits are greater,” adding, “Regulatory authorities in each country, including Korea, are placing weight on the fact that there is no alternative to amyloid antibody treatment.”
All three Alzheimer’s treatments approved by the FDA so far (Aduhelm, Rekembi, and Kysunra) are antibody treatments that target amyloid. Even in the drugs currently in phase 3 clinical trials, amyloid antibodies account for about 30%.
There are also voices of concern in the European medical community about patients’ ‘treatment tourism’ due to the lack of alternatives. Professor John Hardy of University College London in the UK said, “Affluent European patients with early-stage Alzheimer’s disease will go to the US or other regions for treatment.”
Reporter Choi Ji-won [email protected]
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2024-07-28 20:38:29